QA Associate

5 months ago

Toronto, Canada DiaSorin Full time

Diasorin is a global leader in diagnostic solutions, pushing the boundaries of science and technology to create cutting-edge tools that improve healthcare worldwide. With a legacy spanning over 50 years, we've earned our reputation for excellence by developing innovative diagnostic assays and instruments that are trusted by healthcare providers around the world.

Our broad offering of diagnostic tests and Licensed Technology solutions, made available thanks to ongoing investments in research, positions us as the player with the widest range of specialty solutions in the sector and identifies us as the "Diagnostics Specialist."

Why Join Diasorin?

**Impactful Work**: When you join Diasorin, you become part of a team that's dedicated to improving lives. Your contributions will directly impact patient care, making a meaningful difference in the world.

**Global Reach & Innovation**: Our work transcends borders. Joining Diasorin means collaborating with colleagues from all over the world, expanding your horizons, and contributing to global healthcare solutions at the forefront of the diagnostic industry.

**Diverse and Inclusive Culture**: We believe in the strength of diversity, and our inclusive culture reflects this commitment. We value your unique perspective and offer a supportive, collaborative environment where everyone can thrive.

**Join Our Team**: If you're passionate about innovation, diversity, and making a positive impact on healthcare, Diasorin is the place for you. We're looking for passionate and talented individuals who are ready to embrace new challenges and drive healthcare solutions forward.

Job Scope

Participating in the design, creation, and implementation and monitoring of programs and methodologies to ensure that Luminex products meet established specifications, design criteria, quality standards and customer requirements. Sharing responsibility for Quality Assurance operations associated with Luminex products and processes. Thorough knowledge of the Luminex Quality Management System is essential to competently fulfill the duties of the position.

Key Responsibilities and Duties

Review and approve manufacturing records (includes all manufacturing department BPRs) and QC Records (department tests and inspections)

Review and approve Device History Records

Release products for distribution.

Review Product Lot Request records

Review and approve pilot lots

Participate in performing CAPA effectiveness checks, CAPA follow-up and ANR follow-up

Review and approve ECOs and DCOs as assigned

Log, file, maintain and archive various QA records

Prepare materials for QA meetings and, as assigned, present materials at QA meetings.

Coordinate resolution of quality issues with internal personnel and departments

Participate in audits and inspections

Support and participate in other QA related activities as required.

Other duties as assigned.

QUALIFICATIONS

Associate degree in a life science or engineering or equivalent related experience

3 years’ of experience in Quality Assurance activities

1 years’ of experience with participating in formal audits

1 years’ of experience in Medical Device Manufacturing environment

1 years’ knowledge of cGMP regulations (21 CFR 820, CMDR and ISO 13485)

Detail oriented

Competency in use of Microsoft Excel, Word and Outlook

Excellent interpersonal, communication and organizational skills.

Diasorin is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not be discriminated against on the basis of disability.

In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and Canada and to complete the required employment eligibility verification document form upon hire.

The above job description is intended to describe the general content, identify the essential functions, and set forth the requirements for the performance of this job. It is not to be construed as an exhaustive statement of duties, responsibilities, or requirements.

Diasorin reserves the right to modify or amend this job posting as needed to comply with local laws and regulations.

This position is not eligible for partnership with a third-party search firm vendor without expressed, written consent from the Diasorin Human Resources Department.

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